Analyst I, QC Microbiology Testing
Company: Emergent BioSolutions
Posted on: November 5, 2018
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
This is a laboratory testing position with the major responsibilities being daily routine testing and laboratory maintenance tasks. Additional responsibilities involve quality systems support which includes authoring laboratory investigations.
- Basic understanding of compliance/guidance/regulations pertaining to assigned area.
- Performs routine testing following written procedures and limited non-routine testing including validation studies with supervisory oversight.
- Performs testing competently in at least one to two areas of microbiology testing using aseptic and microbiology techniques:
- Release Testing - sterility test, antimicrobial efficacy test
- Microbiological Examination - purity test, filtrate, bacterial endotoxins test, water analysis, growth promotion
- Contamination Control - microbial identification, gram stain, mycology, biological indicators, media fills
- Laboratory Support (Including Quality Systems):
- Identifies and supports change and continuous improvement using LEAN practices such as 5S and Kaizen.
- Conducts peer review (second-person check of QC data).
- Verifies and enters passing results in laboratory information management systems (LIMS).
- LIMS administration functions such as job and sample creation.
- Monitor controlled temperature units.
- Receive, label, and restock reagents and supplies.
- Demonstrates proficiency in the use and maintenance of standard laboratory equipment.
- Works with facilities/metrology to conduct and document execution of work orders to ensure GMP compliant state of labs and equipment.
- Maintains the lab and associated areas using the LEAN 5S concept.
- Participates in laboratory investigations, non-conformance, CAPA and change control activitie
- Works on problems of simple to moderate scope in which analysis of situation or data requires a review of identifiable factors.
- Exercises judgment within defined procedures and practices to determine appropriate action.
- Follows good microbiology laboratory practices and procedures in analyzing situations or data from which answers can be readily obtained.
- Receives general instructions on routine work, detailed instructions on new assignments.
- Ownership - Actively participate in self-development (SLII, IPMP)
- Accountability - Follow through on commitments (PIL), Situational Leadership or additional accountability tools
- Detail oriented - Able to complete required tasks and associated documentation with minimal error
- Adaptability - Maintain positive attitude in a changing work environment
- Communication - Effectively communicate with all levels of manufacturing and support staff
- Actively participate in department level meetings
- Escalate issues through the proper channels
- Live the Core Values
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
Education, Experience & Skills
- Bachelor degree in Microbiology preferred.
- 0-2 years of experience preferred, or equivalent level of skill and experience.
- Previous experience with microbiology assays and aseptic techniques in a GMP manufacturing environment is preferred.
- Hands-on experience with one or more microbiology techniques: membrane filtration, inoculation (broth/agar), serial dilutions, biochemical tests, microbial identification, enumeration, environmental monitoring.
- Personal Competencies: self-awareness, integrity, team player, innovative, and flexible.
- An understanding of cGMP, CFR, USP, and aseptic processing guidelines is preferred.
- Computer skills (MS Office, MS Project) or comparable word-processing and spreadsheet applications is required.
- May require work on weekends, and nights.
Type/keyboard, visual acuity, good hand/eye coordination, stand, walk, sit, twist/turn, climb, reach outward, reach above shoulder, hand dexterity, bend, squat/kneel, sense of feel, sense of hearing, sense of smell, lift/carry 50 lbs, and pull 50 lbs. Use phone, fax, copier and computer. Work outdoors, noise above conversation level, hot/cold temperatures, ventilation needed, multiple locations, restricted access to laboratory, contact with Select Agents and exposure to animals, and animal areas or equipment used in animal areas. Organize/coordinate, analyze/interpret, calibrate precise measurements, problem solve, make decisions, plan, communicate, prepare written communications and prepare transaction documents.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.
Keywords: Emergent BioSolutions, Lansing , Analyst I, QC Microbiology Testing, Professions , Lansing, Michigan
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